K222047

Substantially Equivalent

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

Applicant: Elekta Solutions AB
Product code: IWB
Advisory panel: Radiology
Date received: 2022-07-12
Decision date: 2022-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.